Formulary Group Decisions May 2010
Approved for use in NHS Grampian
Advice subject to review and publication of the awaited SMC advice:
Febuxostat tablets (Adenuric®)
Gout and cytotoxic-induced hyperuricaemia BNF 10.1.4
Febuxostat tablets (Adenuric®) was provisionally approved for inclusion in the Grampian Joint Formulary for restricted use for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol or for whom allopurinol is contraindicated. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist.
Febuxostat tablets (Adenuric®)
Gout and cytotoxic-induced hyperuricaemia BNF 10.1.4
Febuxostat tablets (Adenuric®)
was provisionally approved for inclusion in the Grampian Joint Formulary for restricted use for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol or for whom allopurinol is contraindicated. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist.Fondaparinux sodium, 2.5mg/0.5mL solution for injection, pre-filled syringe (Arixtra®)
Parenteral anticoagulants BNF 2.8.1
Fondaparinux sodium, 2.5mg/0.5mL solution for injection, pre-filled syringe (Arixtra®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of unstable angina or non-ST segment elevation myocardial infarction in patients for whom urgent (<120minutes) invasive management (Percutaneous Coronary Intervention) is not indicated.
Fondaparinux was shown to be non-inferior to a low molecular weight heparin in preventing death, myocardial infarction or refractory ischaemia in the nine days following onset of symptoms. Fondaparinux also had a significantly lower major bleeding event rate than a low molecular weight heparin. Available for restricted use under specialist supervision and recommended for hospital use only.
Parenteral anticoagulants BNF 2.8.1
Fondaparinux sodium, 2.5mg/0.5mL solution for injection, pre-filled syringe (Arixtra®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of unstable angina or non-ST segment elevation myocardial infarction in patients for whom urgent (<120minutes) invasive management (Percutaneous Coronary Intervention) is not indicated.
Fondaparinux was shown to be non-inferior to a low molecular weight heparin in preventing death, myocardial infarction or refractory ischaemia in the nine days following onset of symptoms. Fondaparinux also had a significantly lower major bleeding event rate than a low molecular weight heparin. Available for restricted use under specialist supervision and recommended for hospital use only.
Histrelin acetate, 50mg subcutaneous implant (Vantas®)
Gonadorelin analogues and gonadotrophin-releasing hormone antagonists BNF 8.3.4.2
Histrelin acetate, 50mg subcutaneous implant (Vantas®) was approved for inclusion in the Grampian Joint Formulary for restricted use for palliative treatment of advanced prostate cancer. Histrelin is restricted to use in patients with an anticipated life expectancy of at least one year in whom annual administration will offer advantages.
In a single-arm study, histrelin provided effective suppression of testosterone levels in patients with advanced prostate cancer. It requires less frequent administration than other leuteinising hormone releasing hormone (LHRH) agonists. Other LHRH agonists are available at a lower acquisition cost.
Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist - prescribing in primary care is dependent on appropriate arrangements for on-going training and clinical governance being in place.
Gonadorelin analogues and gonadotrophin-releasing hormone antagonists BNF 8.3.4.2
Histrelin acetate, 50mg subcutaneous implant (Vantas®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for palliative treatment of advanced prostate cancer. Histrelin is restricted to use in patients with an anticipated life expectancy of at least one year in whom annual administration will offer advantages.
In a single-arm study, histrelin provided effective suppression of testosterone levels in patients with advanced prostate cancer. It requires less frequent administration than other leuteinising hormone releasing hormone (LHRH) agonists. Other LHRH agonists are available at a lower acquisition cost.
Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist - prescribing in primary care is dependent on appropriate arrangements for on-going training and clinical governance being in place.
Lenalidomide capsules (Revlimid®)
Other immunomodulating drugs BNF 8.2.4
Lenalidomide capsules (Revlimid®) was approved for inclusion in the Grampian Joint Formulary for restricted use in combination with dexamethasone, for the treatment of multiple myeloma adult patients who have received at least two prior lines of therapy.
Lenalidomide plus dexamethasone significantly increased the time to progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy.
Taking into account the orphan drug status of lenalidomide and the substantial survival benefit it appears to offer, SMC concluded that the economic case was demonstrated. Available for restricted use under specialist supervision and recommended for hospital use only. Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Other immunomodulating drugs BNF 8.2.4
Lenalidomide capsules (Revlimid®)
was approved for inclusion in the Grampian Joint Formulary for restricted use in combination with dexamethasone, for the treatment of multiple myeloma adult patients who have received at least two prior lines of therapy.
Lenalidomide plus dexamethasone significantly increased the time to progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy.
Taking into account the orphan drug status of lenalidomide and the substantial survival benefit it appears to offer, SMC concluded that the economic case was demonstrated. Available for restricted use under specialist supervision and recommended for hospital use only. Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Raltegravir tablets (Isentress®)
HIV infection BNF 5.3.1
Raltegravir, 400mg film-coated tablet (Isentress®) was approved for inclusion in the Grampian Joint Formulary for restricted use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
Restricted to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions. Available for restricted use under specialist supervision and recommended for hospital use only.
HIV infection BNF 5.3.1
Raltegravir, 400mg film-coated tablet (Isentress®)
was approved for inclusion in the Grampian Joint Formulary for restricted use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
Restricted to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions. Available for restricted use under specialist supervision and recommended for hospital use only.
Tobramycin 300mg/4mL nebuliser solution (Bramitob®)
Aminoglycosides BNF 5.1.4
Tobramycin 300mg/4mL nebuliser solution (Bramitob®) was approved for inclusion in the Grampian Joint Formulary for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older. Available for restricted use under specialist supervision and recommended for hospital use only. Consideration should be given to official guidance on the appropriate use of antibacterial agents and therapy should be initiated by a physician experienced in the management of cystic fibrosis.
Aminoglycosides BNF 5.1.4
Tobramycin 300mg/4mL nebuliser solution (Bramitob®) was approved for inclusion in the Grampian Joint Formulary for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older. Available for restricted use under specialist supervision and recommended for hospital use only. Consideration should be given to official guidance on the appropriate use of antibacterial agents and therapy should be initiated by a physician experienced in the management of cystic fibrosis.
Ustekinumab injection (Stelara®)
Drugs affecting the immune response, cytokine modulators BNF 13.5.3
Ustekinumab, 45mg solution for injection (Stelara®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA).
Significantly more patients treated with ustekinumab achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI) score at week 12, compared with those treated with a tumour necrosis factor alpha antagonist.
Continued treatment should be restricted to patients who achieve a PASI 75 response within 16 weeks.
This advice takes account of the benefits of, and is dependent upon the continuing availability of a Patient Access Scheme that improves the cost-effectiveness of ustekinumab. Available for restricted use under specialist supervision and recommended for hospital use only.
Drugs affecting the immune response, cytokine modulators BNF 13.5.3
Ustekinumab, 45mg solution for injection (Stelara®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA).
Significantly more patients treated with ustekinumab achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI) score at week 12, compared with those treated with a tumour necrosis factor alpha antagonist.
Continued treatment should be restricted to patients who achieve a PASI 75 response within 16 weeks.
This advice takes account of the benefits of, and is dependent upon the continuing availability of a Patient Access Scheme that improves the cost-effectiveness of ustekinumab. Available for restricted use under specialist supervision and recommended for hospital use only.
Not approved for use in NHS Grampian
Certolizumab pegol injection (Cimzia®)
Drugs that suppress the rheumatic disease process, cytokine modulators 10.1.3
Certolizumab pegol injection (Cimzia®) is not recommended for use within NHS Scotland [
SMC 590/09].
Licensed indication under review:
Drugs that suppress the rheumatic disease process, cytokine modulators 10.1.3
Certolizumab pegol injection (Cimzia®)
is not recommended for use within NHS Scotland [
SMC 590/09].
Licensed indication under review:
- in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying antirheumatic drugs, including methotrexate, has been inadequate.
- monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
In patients who continued to receive methotrexate despite an incomplete response, the addition of certolizumab pegol produced a rapid and sustained reduction in the signs and symptoms of rheumatoid arthritis, inhibited structural joint damage progression and improved physical function compared with placebo.
However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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